Methods and devices for creating tissue plications

ABSTRACT

Devices and methods for forming and securing a tissue plication are disclosed herein. In one aspect, a tissue manipulation device is described that includes a first jaw member pivotally coupled to a distal end of an elongate shaft and having an articulating portion located distal to the proximal end of the first jaw member. The device also includes a second jaw member pivotally coupled to the first jaw member such that the jaws move in a first plane, and a fastener delivery member attached to the second jaw member. The articulating portion of the first jaw member is configured to move the first and second jaw members between a straight configuration in which a longitudinal axis of the elongate shaft is contained within the first plane and an articulated configuration in which the longitudinal axis of the elongate shaft is transverse to the first plane.

FIELD

This invention relates generally to devices and methods for performingsurgical procedures, and more particularly to endoscopic devices andmethods for forming endoluminal plications to reduce the volume of thegastric cavity.

BACKGROUND

Metabolic disease is a serious medical condition that affects more than30% of the U.S. population and can contribute significantly to morbidityand mortality. Complications associated with metabolic disease includeobesity, hypertension, diabetes, coronary artery disease, stroke,congestive heart failure, multiple orthopedic problems, pulmonaryinsufficiency, sleep apnea, infertility, and markedly decreased lifeexpectancy. Additionally, the complications or co-morbidities associatedwith metabolic disease, such as obesity, often affect an individual'squality of life. Accordingly, the monetary, physical, and psychologicalcosts associated with metabolic disease can be substantial. For example,it is estimated that costs related to obesity alone exceed more than 100billion dollars annually.

A variety of bariatric surgical procedures have been developed to treatcomplications of metabolic disease, such as obesity. The most common ofthese is the Roux-en-Y gastric bypass (RYGB). In a RYGB procedure, asmall stomach pouch is separated from the remainder of the gastriccavity and attached to a resectioned portion of the small intestine.However, because this complex procedure requires a great deal ofoperative time, as well as extended and often painful post-operativerecovery, the RYGB procedure is generally only utilized to treat peoplewith morbid obesity.

In view of the highly invasive nature of the RYGB procedure, other lessinvasive bariatric procedures have been developed such as the Fobipouch, bilio-pancreatic diversion, gastroplasty (“stomach stapling”),vertical sleeve gastrectomy, and gastric banding. In addition,implantable devices are known which limit the passage of food throughthe stomach. Gastric banding procedures, for example, involve theplacement of a small band around the stomach near the junction of thestomach and the esophagus to restrict the passage from one part of thedigestive tract to another, thereby affecting a patient's feeling ofsatiety.

While the above-described bariatric procedures are commonly used for thetreatment of morbid obesity (i.e., greater than 100 pounds over one'sideal body weight), the risks of these procedures often outweigh thepotential benefits for the growing segment of the population that isconsidered overweight. The additional weight carried around by thesepersons can still result in significant health complications, but doesnot justify more invasive treatment options. However, becauseconservative treatment with diet and exercise alone may be ineffectivefor reducing excess body weight, there is a need for treatment optionsthat are less invasive and lower cost than the procedures discussedabove.

It is known to create cavity wall plications through both laparoscopicand endoscopic procedures. Laparoscopic plication techniques can becomplicated and complex, however, as one or more surgical entry portsmust be employed to gain access to the surgical site. Furthermore,laparoscopically approaching the stomach often requires separating thesurrounding omentum prior to plication formation. In endoscopicprocedures, plication depth has traditionally suffered due to the sizerestrictions of the endoscopic lumen. For example, the rigid length anddiameter of a surgical device are limited based on what sizes can bereliably and safely passed trans-orally into the stomach. Furthermore,access and visibility within the gastric and peritoneal cavities isprogressively limited in an endoscopic procedure as the extent of thereduction increases because the volume of the gastric cavity is reduced.

In addition, prior art devices for forming endoluminal plications oftenutilize opposing jaws and a grasper element to draw tissue between thejaws. The prior art devices approach the cavity wall such that alongitudinal axis of the device is perpendicular to the cavity wall. Thegrasper element can then be advanced along a parallel axis, and used todraw tissue into the jaws to create the fold. One exemplary prior artdevice is described in U.S. Patent Publication No. 2005/0251166 toVaughan et al., the contents of which are hereby incorporated byreference in their entirety.

FIG. 1A illustrates the device disclosed by Vaughan et al., whichincludes a tubular body 12 connected to a lower jaw 20. The lower jaw isin turn connected to an upper jaw 22, and the upper jaw is connected toa launch tube 44. By moving the launch tube proximally and distally, thejaws can be moved between the positions shown in FIGS. 1A and 1B.

In use, the device disclosed by Vaughan et al. is extended from atransport device, such as an endoscope, and positioned such that alongitudinal axis of the device is perpendicular to a tissue wall. Atissue grasping element 102 is utilized to grab the tissue wall and pullit into the open jaws, as shown in FIG. 2. The jaws are then moved to aclosed position and a fastener is delivered through the launch tube 44to secure the plication.

However, the geometry of the device limits the size of the plicationthat can be formed to approximately the length of the jaws, as thegrasper can only draw the cavity wall tissue to the center of the jawsand no farther. This maximum fold depth D is shown in the side view ofthe device of Vaughan et al. shown in FIG. 3.

Accordingly, it is desirable to have methods and devices for formingtissue folds, such as serosa-to-serosa tissue folds within the gastriclumen, that overcome the aforementioned problems.

SUMMARY

The present invention generally provides devices and methods for formingand securing plications of tissue. More particularly, the devices andmethods of the present invention can be used to create and secureplications of gastric tissue on the anterior and posterior walls of apatient's gastric cavity to reduce the volume of the cavity. Particularfeatures of the devices and methods described herein provide advantagesover prior art devices including, for example, the ability to createplications having a depth greater than a length of the surgicalinstrument used to secure the plication.

In one aspect, a tissue manipulation device is provided that includes afirst jaw member pivotally coupled to a distal end of an elongate shaftat a proximal end thereof, the first jaw member having an articulatingportion located distal to the proximal end of the first jaw member. Thedevice further includes a second jaw member pivotally coupled to thefirst jaw member at a location distal to the articulating portion, thefirst and second jaw members being configured to open in a first plane.The device also includes a fastener delivery member attached to thesecond jaw member and having an inner lumen extending therethrough. Thearticulating portion of the first jaw member can be configured to movethe first and second jaw members between a straight configuration inwhich a longitudinal axis of the elongate shaft is contained within thefirst plane and an articulated configuration in which the longitudinalaxis of the elongate shaft is transverse to the first plane.

By articulating the first and second jaw members into a positiontransverse to the longitudinal axis of the elongate shaft, the first andsecond jaw members can avoid the limitations discussed above related tothe depth of folds that can be created using the jaws. This can beaccomplished, for example, by pulling tissue transversely through thejaws rather than into the open jaws toward their center pivot. Forexample, in some embodiments, the longitudinal axis of the elongateshaft can be perpendicular to the first plane in the articulatedconfiguration. As a result, if the elongate shaft approaches a tissuewall along a perpendicular axis, the first and second jaws can bearticulated such that they are parallel to the tissue wall. Tissue canthen be drawn through the jaws from one side to another, allowing thecreation of a tissue fold of any depth.

The articulating portion of the tissue manipulation device can have avariety of forms. For example, in some embodiments, the articulatingportion can include a hinge. The hinge can be formed in the first jawmember and positioned between the attachment of the first jaw member tothe elongate shaft and the connection to the second jaw member. In otherembodiments, the articulating portion can include a plurality of jointedsegments. Each segment can be configured to provide a certain range ofmotion, such that the plurality together can provide a greater range ofmotion. The number of segments can be selected according to the desiredtotal amount of articulation (e.g., 90 degrees, greater than 90 degrees,etc.), the degree of motion provided by each individual segment, thedesired length of the device, etc. In still other embodiments, thearticulating portion can include a ball-and-socket joint. Alternatively,the articulating portion can comprise a plurality of ball-and-socketjoints similar to the plurality of jointed segments described above.

In some embodiments, the device can further include an articulationactuating member configured to control the articulating portion. Thearticulation actuating member can have a number of different forms. Forexample, in some embodiments, the articulation actuating member caninclude one or more connecting members extending proximally from alocation distal to the articulating portion. The connecting members canhave a variety of forms, including cables, wires, ribbons, bands, etc.In such an embodiment, the one or more connecting members can be pulledto effect movement of the first and second jaws via movement of thearticulating portion. A number of other embodiments of the articulationactuating member are possible as well. These include, for example, shapememory materials, electrically driven actuators, etc. In certainembodiments, the one or more cables or other connecting members of anarticulation actuating member can be contained in a lumen of a sheathcovering the articulating portion. A sheath or other protective coveringcan be employed to cover other embodiments of an articulation actuatingmember (e.g., springs, linkages, etc.) to prevent protrusions frominterfering with use of the device inside a patient's body.

The first and second jaw members of the tissue manipulation device canbe operated by movement of the fastener delivery member whether in thestraight configuration or articulated configuration. For example, insome embodiments, the second jaw member can have a channel formedtherein and the fastener delivery member can be configured to urge thefirst and second jaw members between a low-profile deliveryconfiguration in which a distal portion of the fastener delivery memberis positioned substantially within the channel and an open configurationin which the distal portion of the fastener delivery member ispositioned substantially outside of the channel. Movement of thefastener delivery member in the proximal direction can, in someembodiments, urge the first and second jaw members into an openposition. Conversely, movement of the fastener delivery member in thedistal direction can urge the first and second jaw members into a closeconfiguration effective to grasp tissue disposed therebetween.

The fastener delivery member itself can have a variety ofconfigurations. In some embodiments, the distal end of the fastenerdelivery member can be pivotally coupled to the second jaw member. Inother embodiments, the fastener delivery member can include a distallylocated flexible portion. In certain embodiments, the fastener deliverymember can also include a rigid portion proximal to the flexibleportion. The combination of the rigid and flexible portions can beutilized to impart urging force to the first and second jaw members in avariety of positions in either the straight or articulatedconfigurations.

In some embodiments, the fastener delivery member can include a fastenerdeployment assembly within the inner lumen of the fastener deliverymember. The fastener deployment assembly can be configured to introducea fastener through tissue disposed between the first and second jawmembers to secure a tissue plication. This can be accomplished in avariety of manners. For example, in some embodiments, the fastenerdeployment assembly can include a needle having a tip moveable out ofthe fastener delivery member and through openings formed in the firstand second jaw members. The needle can include an inner lumen in whichone or more fasteners are disposed. A variety of different fasteners canbe employed and, in some embodiments, each fastener can include twoanchors joined by a suture or other connecting element. A first anchorcan be ejected from the fastener delivery member on a first side oftissue disposed between the first and second jaw members, and a secondanchor can be ejected from the fastener delivery member on a second sideof the tissue. The connecting suture can be utilized to maintain the twotissue interfacing elements in close apposition to secure the tissuefold. Alternatively, both anchors can be ejected on a same side oftissue at two locations, with the connecting suture passing through thetissue and extending between the two anchors.

In another aspect, a tissue acquisition and fixation system is providedthat includes an elongate shaft having proximal and distal ends, and anend effector having first and second jaws configured to pivot in a firstplane. The end effector can be coupled to the distal end of the elongateshaft and configured to pivot relative to the elongate shaft in a secondplane that is transverse to the first plane. The system can furtherinclude a flexible fastener delivery member extending from the elongateshaft and coupled to the second jaw, as well as a tissue grasper capableof moving independently from the end effector and configured to drawtissue through the first and second jaws.

In some embodiments, the end effector can be configured to move betweenan insertion configuration in which a longitudinal axis of the elongateshaft is contained within the first plane and a grasping configurationin which the longitudinal axis of the elongate shaft is transverse tothe first plane. This movement can be similar to the device describedabove. In certain embodiments, the longitudinal axis of the elongateshaft can be perpendicular to the first plane in the graspingconfiguration.

In still another aspect, a method of acquiring and fixating tissue isprovided that includes inserting into a body lumen a tissue grasper, anelongate shaft, and an end effector having first and second jaws thatare pivotally coupled to a distal end of the elongate shaft. The methodfurther includes pivoting the end effector with respect to the elongateshaft in a first plane, and pivoting the first and second jaws in asecond plane that is transverse to the first plane. The method alsoincludes positioning the tissue grasper to engage tissue, drawing tissuethrough the first and second jaws by moving the tissue graspertransversely with respect to the first and second jaws, and delivering afastener through the tissue disposed between the first and second jawsfrom a fastener delivery member coupled to the second jaw.

In some embodiments, inserting the end effector and elongate shaft intoa body lumen can include positioning the elongate shaft perpendicular toan inner surface of the body lumen. Further, pivoting the end effectorin the first plane can include positioning the end effector such that alongitudinal axis of the end effector is parallel to the inner surfaceof the body lumen. In this position, tissue can be drawn through thefirst and second jaws in a transverse direction (i.e., a directiontransverse to a longitudinal axis of the first and second jaws) bymoving the tissue grasper transversely with respect to the first andsecond jaws. Furthermore, in some embodiments, moving the tissue graspertransversely with respect to the first and second jaws can includemoving the tissue grasper perpendicular to a longitudinal axis of thefirst and second jaws. In this configuration, tissue can be drawnthrough the jaws to any depth, as the pivotal connection between thefirst and second jaws does not impede the progress of the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The aspects and embodiments of the invention described above will bemore fully understood from the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1A is an illustration of a prior art tissue manipulation device inan open jaw configuration;

FIG. 1B is an illustration of the prior art tissue manipulation deviceof FIG. 1A in a closed jaw configuration;

FIG. 2 is a top view of the prior art tissue manipulation device of FIG.1A receiving tissue between open jaw members;

FIG. 3 is a side view of the prior art tissue manipulation device ofFIG. 1A;

FIG. 4 is an illustration of one embodiment of a surgical instrumentfeaturing a tissue manipulation device of the present invention;

FIG. 5A is a side view of one embodiment of an articulating tissuemanipulation device in an insertion configuration;

FIG. 5B is a side view of the device of FIG. 5A in an openconfiguration;

FIG. 5C is a side view of the device of FIG. 5A in a closedconfiguration;

FIG. 6A is a perspective view of the tissue manipulation device of FIG.5A;

FIG. 6B is a top view of the tissue manipulation device of FIG. 6A;

FIG. 6C is a top view of the tissue manipulation device of FIG. 6A in anarticulated configuration;

FIG. 7 is an exploded view of the surgical instrument of FIG. 4 and oneembodiment of a fastener deployment assembly;

FIG. 8 is an exploded view of the fastener deployment assembly of FIG.7;

FIG. 9 is a top view of one embodiment of a tissue manipulation devicein an articulated configuration;

FIG. 10 is a top view of the tissue manipulation device of FIG. 8receiving tissue between open jaw members;

FIG. 11 is a top view of one embodiment of a tissue manipulation deviceapplying a second fastener to form an extended tissue plication;

FIG. 12 is a side cross-sectional view of one embodiment of aserosa-to-serosa tissue fold secured with a fastener;

FIG. 13A is a perspective view of one embodiment of an articulatingportion of a tissue manipulation device;

FIG. 13B is a perspective view of another embodiment of an articulatingportion of a tissue manipulation device;

FIG. 13C is a perspective view of still another embodiment of anarticulating portion of a tissue manipulation device;

FIG. 14 is a perspective view of one embodiment of a tissue manipulationdevice having an articulation actuating member;

FIG. 15 is a cross-sectional view of one embodiment of a sleeve housingan articulation actuating member;

FIG. 16A illustrates an exemplary plication positioned in the upperregion of the gastric cavity;

FIG. 16B illustrates an exemplary method of forming multiple plicationsby fanning out from the position of the plication shown in FIG. 16A;

FIG. 17A illustrates an exemplary plication created in the lower regionof the gastric cavity;

FIG. 17B illustrates an exemplary method of forming a second plicationby extending from an end point of the plication shown in FIG. 17A;

FIG. 17C illustrates an exemplary method of forming a third plicationoff the plications shown in FIG. 17B; and

FIG. 18 illustrates an exemplary combination of the various plicationpatterns shown in FIGS. 16A-17C.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the devices and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those skilled in the art willunderstand that the devices and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

The terms “a” and “an” can be used interchangeably, and are equivalentto the phrase “one or more” as utilized in the present application. Theterms “comprising,” “having,” “including,” and “containing” are to beconstrued as open-ended terms (i.e., meaning “including, but not limitedto,”) unless otherwise noted. The terms “about” and “approximately” usedfor any numerical values or ranges indicate a suitable dimensionaltolerance that allows the composition, part, or collection of elementsto function for its intended purpose as described herein. These termsgenerally indicate a ±10% variation about a central value. Componentsdescribed herein as being coupled may be directly coupled, or they maybe indirectly coupled via one or more intermediate components. Therecitation of any ranges of values herein is merely intended to serve asa shorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited. All methods described herein can be performed inany suitable order unless otherwise indicated herein or otherwiseclearly contradicted by context. The use of any and all examples, orexemplary language (e.g., “such as”), provided herein is intended merelyto better illuminate the invention and does not impose a limitation onthe scope of the invention unless otherwise claimed. No language in thespecification should be construed as indicating any non-claimed elementas essential to the practice of the invention.

The present invention generally provides devices and methods forapposing, forming, and securing tissue plications. These generallyinvolve the creation of tissue plications for the reduction of cavitycapacity, but may include the closure or repair of intentional(gastrotomy, colotomy, or enterotomy closure from Natural OrificeTranslumenal Endoscopic Surgery (NOTES™), etc.) or unintentional(fistula, gastrointestinal leaks, etc.) tissue defects as well as thecreation valves or restrictions to alter (e.g., enhance or impede) theflow of substances (e.g., Nissen fundoplication). In general, devicesare provided having a set of pivoting jaws that can be articulated suchthat the jaws can be positioned parallel to a tissue wall and a tissuegrasper can be used to draw tissue through the open jaws transversely.One or more of the jaws can be coupled to the distal end of an elongateshaft or other surgical instrument that can be configured, for example,to be inserted into a patient's stomach through the esophagus. Thesurgical instrument itself can also include an articulating portion toallow the jaws to be positioned in a range of locations on, for example,both the anterior and posterior inner walls of the stomach. In use, thesurgical instrument can approach a tissue wall along a perpendicularaxis thereof and the jaws can be articulated to a position parallel tothe tissue wall. A tissue grasper can then be used to engage the tissuewall and draw tissue through the open jaws by moving transversely acrossthe jaws, thereby forming a tissue plication, or fold, disposed betweenthe jaws. The jaws can then be closed and a fastener applied through atube connected to the jaws to secure the plication.

By forming and fastening one or more of these plications, the volume orcapacity of a cavity, such as the gastric cavity, can be reduced withoutthe need for more invasive surgical procedures. The devices and methodsof the present invention can be used to treat a wide variety ofcomplications that develop as a result of metabolic disease. One commonexample of such a complication is obesity. However, non-obeseindividuals suffering from other metabolic disease complications, suchas patients with low-Body Mass Index (BMI) type 2 diabetes, can also betreated using the teachings of the present invention.

As noted above, the devices disclosed herein can be at least partiallypositioned inside a patient's body cavity through an orifice forminimally invasive surgical procedures. Typically, the devices areinserted through a patient's mouth and extended down their esophagusinto the stomach. However, one skilled in the art will appreciate thatany of the surgical device components disclosed herein can also beadapted for use in other surgical procedures, whether minimally invasiveor open.

The various components of the devices disclosed herein can be formedfrom any of a variety of materials known in the art and suitable for usein surgical devices. For example, the various components can be formedfrom metal (e.g., stainless steel, titanium, or other biocompatiblemetals), plastic (e.g., polyetheretherketone (PEEK), polycarbonate,polypropylene, ultem, or other biocompatible polymers), elastomers(e.g., silicone or other biocompatible elastomers) and/or combinationsthereof.

FIG. 4 illustrates one embodiment of a surgical instrument 400 of thepresent invention. The surgical instrument 400 may be utilized forendoluminally accessing tissue and includes a tissue manipulation device402 that can create and secure one or more tissue plications. Thesurgical instrument 400 generally comprises an elongate shaft 404, whichmay be embodied as a flexible catheter or tubular body, that isconfigured to be advanced into a body lumen either transorally,percutaneously, laparoscopically, etc. The elongate shaft 404 may beconfigured to be torqueable through various methods, e.g., utilizing abraided tubular construction, such that when an attached handle 406 ismanipulated and/or rotated by a user from outside the patient's body,the longitudinal and/or torqueing force can be transmitted along theelongate shaft 404 such that the distal end of the shaft is advanced,withdrawn, or rotated in a corresponding manner.

FIGS. 5A-5C illustrate a side view of one embodiment of a tissuemanipulation device 402 that can be disposed as an end effector on thedistal end of the elongate shaft 404. The tissue manipulation device isgenerally used to contact and secure tissue folds. The device 402 can beconnected to the distal end of the elongate shaft 404 via a pivotalcoupling 502. A first lower jaw member 504 can extend distally from thepivotal coupling 502 and a second upper jaw member 506 can be pivotallycoupled to first jaw member via a jaw pivot 508. The position of the jawpivot 506 can vary along the first jaw 504 depending upon a number offactors including, for example, the desired size of the “bite” oropening for accepting tissue between the first and second jaw members,the amount of closing force applied by the first and second jaw members,etc. One or both of the first and second jaw members 504, 506 can alsohave a number of protrusions, projections, grasping teeth, texturedsurfaces, etc., 510 on the surface or surfaces thereof to facilitate theadherence of tissue between the jaw members.

The tissue manipulation device 402 can also include a fastener deliverymember 512 that can extend from the handle 406 through the elongateshaft 404 and protrude distally from the end of the elongate shaft. Adistal end of the fastener delivery member 512 can be pivotally coupledto the second jaw member 506 at a delivery member pivot 514. A distalportion of the fastener delivery member 512 can be pivoted into positionwithin a channel or groove defined in the second jaw member 506 tofacilitate a low-profile configuration of the tissue manipulation device402, as shown in FIG. 5A. This configuration can be utilized, forexample, when introducing the device into a patient's body. The fastenerdelivery member 512 can also articulate out of the channel in the secondjaw member 506 when moved in a proximal or distal direction (as shown inFIGS. 5B and 5C). Furthermore, and as described in more detail below,movement of the fastener delivery member 512 can urge the first andsecond jaw members 504, 506 into either an open or closed configuration.

For example, the fastener delivery member 512 can be advanced from itsproximal end at the handle 406 such that the portion of the fastenerdelivery member 512 which extends distally from the elongate shaft 404is forced to rotate at the delivery member pivot 502 and reconfigureitself such that the exposed portion forms a curved or arcuate shapethat positions an opening at the distal end of the fastener deliverymember to be perpendicular to the second jaw member 506. Such aconfiguration is shown with respect to the tissue manipulation deviceillustrated in FIG. 5C. The fastener delivery member 512, or at leastthe exposed portion thereof, can be fabricated from a highly flexiblematerial or it may be fabricated, e.g., from Nitinol tubing materialwhich is adapted to flex, e.g., via circumferential slots, to permitbending.

The tissue manipulation device 402 can also include an articulationportion 516 configured to allow the first and second jaw members 504,506 to pivot, rotate, or articulate with respect to the elongate shaft404. The articulation portion 516 can be positioned anywhere along thetissue manipulation device 402, or between the tissue manipulationdevice 402 and the elongate shaft 404. In an exemplary embodiment, thearticulation portion 516 can be formed along the length of the first jawmember 504 at a position between the pivotal coupling 502 and the jawpivot 508 (i.e., at a position distal to the proximal end of the firstjaw member 504 and proximal to the connection between first jaw memberand the second jaw member 506). Positioning the articulating portion 516in this manner can allow the jaws to be efficiently articulated withoutrequiring additional adjustment of the remainder of the surgicalinstrument (e.g., the elongate shaft, etc.). In other embodiments,however, the articulating portion 516 can be an intermediate membercoupling the first jaw member 504 to the elongate shaft 404. In such anembodiment, the first jaw member 504 can be pivotally coupled to thearticulating portion 516, and the articulating portion can in turn becoupled to the distal end of the elongate shaft 404.

FIGS. 6A-6C illustrate exemplary movement provided by the articulatingportion 516. FIG. 6A illustrates the tissue manipulation device 402 in astraight configuration. In this configuration, a first plane 602,defined as the plane in which the first jaw member 504 and the secondjaw member 506 move with respect to each other, contains a longitudinalaxis 604 of the elongate shaft 404. In other words, the first plane 602and the longitudinal axis 604 are coplanar. FIG. 6B illustrates a topview of the straight configuration, showing that the first plane 602contains the longitudinal axis 604 of the elongate shaft 404. Thisstraight configuration, in combination with the low-profileconfiguration of the first and second jaw members shown in FIG. 5A, canbe used to deliver the tissue manipulation device 402 into a patient'sbody. As mentioned above, the device can be inserted transorally,through an endoscope, an endoscopic device, or directly.

The tissue manipulation device 402 can be advanced to a tissue wallalong an axis perpendicular to the tissue wall and, prior to use, can berotated into a position parallel to the tissue wall by actuating thearticulating portion 516. The articulating portion 516 can cause thefirst and second jaw members 504, 506 to move between the straightconfiguration shown in FIGS. 6A and 6B to an articulated configurationshown in the top view of FIG. 6C. In the articulated configuration, thefirst plane 602 (i.e., the plane in which the first and second jawmembers open and close) can be transverse to the longitudinal axis 604of the elongate shaft 404. In other words, the articulation portion 516can pivot or move the tissue manipulation device 402 with respect to theelongate shaft 404 in a second plane 606 that is transverse to the firstplane 602. While the articulating portion 516 can be configured torotate the first and second jaw members to any degree (e.g., less than90° from the longitudinal axis 604, or greater than 90° from thelongitudinal axis 604), in some embodiments the articulating portion isconfigured to rotate the first and second jaw members approximately 90°from the longitudinal axis 604 such that the first and second jawmembers are substantially parallel to the tissue wall. Such aconfiguration can allow tissue to be drawn through the first and secondjaw members transversely, as is described in more detail below.

Once desirably positioned with respect to a tissue wall, the fastenerdelivery member 512 can be urged proximally via its proximal end athandle 406. Because of the pivotal coupling 502 and the relativepositioning of the jaw pivot 508 along the first jaw member 504 and thedelivery member pivot 514 along the second jaw member 506, the proximalmovement of the fastener delivery member 512 can effectively articulatethe second jaw 506 into an expanded jaw configuration, which is shown inthe straight configuration in FIG. 5B. Proximally urging the fastenerdelivery member 512 can also urge the first jaw member 504 to pivotabout the pivotal coupling 502 such that the first jaw member 504 canform an angle relative to a longitudinal axis of the elongate shaft 404.The opening of the second jaw member 506 relative to the first jawmember 504 can create a jaw opening 518 for grasping or receivingtissue. Moreover, the tissue manipulation device 402 can also include astop located adjacent to the pivotal coupling 502 or within the coupling502 itself. The effect of moving the fastener delivery member 512 can beidentical regardless of whether the tissue manipulation device 402 is inthe straight configuration of FIGS. 6A and 6B or the articulatedconfiguration shown in FIG. 6C, though FIGS. 5A-5C show the device inthe straight configuration for ease of illustration. These jawconfigurations can be identically achieved in the articulatedconfiguration. Furthermore, in use, the actuation of the articulationportion 516 and the fastener delivery member 512 can be performed in anyorder. For example, the tissue manipulation device 402 can be moved fromthe straight configuration to the articulated configuration prior tourging the first and second jaw members from the low-profileconfiguration of FIG. 5A, or the jaw members can be opened prior toarticulating the device using the articulation portion 516.

After the fastener delivery member 512 has been urged proximally tocreate the jaw opening 518, it can be locked into place, thereby lockingthe jaw configuration as well. Moreover, having the fastener deliverymember 512 urge the first and second jaw members 504, 506 in this wayeliminates the need for a separate jaw articulation and/or lockingmechanism. Once any tissue has been pulled or manipulated between thefirst and second jaw members 504, 506, as is discussed in more detailbelow, the fastener delivery member 512 can be advanced distally to urgethe first and second jaw members 504, 506 into a closed configuration,as shown in FIG. 5C (jaws are shown in the straight configuration). Asthe fastener delivery member 512 is advanced distally through theelongate body 404, the first jaw member 504 can be maintained at thesame angle relative to the tissue to further facilitate manipulation ofthe grasped tissue.

The fastener delivery member 512 can include a flexible portion 520positioned distally of a rigid portion 522. Although the fastenerdelivery member 512 can be fabricated from a combination of materialshaving differing flexibilities, it can also be fabricated from a singlematerial, as mentioned above, where the flexible portion 520 can beconfigured, e.g., by slotting, to allow for bending of the fastenerdelivery member in a plane to form a single curved or arcuate sectionwhile the rigid section 522 can extend at least partially into theelongate shaft 12 to provide column strength to the fastener deliverymember while it is urged distally upon the second jaw member 506 andupon any tissue disposed between the first and second jaw members. Theflexibility provided by the flexible portion 520 also allows thefastener delivery member 512 to effectively urge the first and secondjaw members between the various positions discussed above regardless ofwhether the tissue manipulation device 402 is in the straightconfiguration of FIGS. 6A and 6B or the articulated configuration ofFIG. 6C.

In order to securely fasten any tissue engaged between the first andsecond jaw members 504, 506, a fastener deployment assembly 700 (shownin FIG. 7) can be urged through the handle 406 and out through thefastener delivery member 512. The fastener deployment assembly 700 canpass through the tissue disposed between the first and second jawmembers and through an opening 608 formed in the first jaw member 504(shown in FIG. 6A). After the fastener deployment assembly 700 has beenpassed through the tissue between the first and second jaw members 504,506, one or more tissue anchors may be deployed for securing the tissue,as described below.

The fastener deployment assembly 700 can be deployed through thesurgical instrument 400 by introducing the fastener deployment assemblyinto the handle 406 and through the elongate shaft 404, as shown in theexploded view of FIG. 7. In particular, a needle assembly 702 can beadvanced from the fastener delivery member 512 into or throughapproximated tissue. After the needle assembly 702 has been advancedthrough the tissue, an anchor assembly 704 can be deployed or ejected,as described below. The anchor assembly 704 can be positioned within thedistal portion of a sheath 706 that extends from a needle control orhousing 708. After the anchor assembly 704 has been fully deployed fromthe sheath 706, the spent fastener deployment assembly 700 can beremoved from the surgical instrument 400 and a new or reloaded fastenerdeployment assembly can be introduced without having to remove thesurgical instrument 400 from the patient. The length of the sheath 706can be such that it can be passed entirely through the length of theelongate shaft 404 to enable the deployment of the needle assembly 702into and/or through the tissue.

FIG. 8 illustrates a more detailed exploded view of the fastenerdeployment assembly 700. As shown in the figure, the elongate andflexible sheath or catheter 706 can extend removably from the needlecontrol or housing 708. The sheath 706 and housing 708 can be coupledvia an interlock 802 that can be adapted to allow for the securement aswell as the rapid release of the sheath 706 from the housing 708 throughany number of fastening methods, e.g., threaded connection, press-fit,releasable pin, etc. A needle body 804 can extend from the distal end ofthe sheath 706 while maintaining communication between an inner lumen ofthe sheath 706 and an opening 806 formed in a distal end of the needle.

An elongate pusher 808 can comprise a flexible wire that can betranslationally disposed within the sheath 706 and movably connectedwithin the housing 708. A proximally-located actuation member 810 may berotatably or otherwise connected to the housing 708 to selectivelyactuate the translational movement of the elongate pusher 808 relativeto the sheath 706 for deploying the anchors from the needle opening 806.The anchor assembly 704 can be positioned distally of the elongatepusher 808 within the sheath 706 for deployment from the sheath. In use,the elongate pusher 808 can be advanced using the actuation member 810to push the anchor assembly 704 distally down the sheath 706 and,ultimately, out of the needle opening 806.

The anchor assembly 704 can, in some embodiments, comprise a firstdistal anchor 814 and a second proximal anchor 816. The anchors 814, 816can be any of a variety of anchors capable of being delivered throughthe sheath 706 and expanding or orienting themselves upon ejection so asto exert a force against tissue. The anchors 814, 816 can be connectedto each other using a suture or other connecting member such that thefirst distal anchor 814 can be ejected on a first side of a tissueplication and the second proximal anchor 816 can be ejected on a secondside of a tissue plication. Alternatively, in some embodiments bothanchors 814, 816 can be ejected on a same side of a tissue plication attwo locations, with the suture or connecting member extending throughthe plication and between the two anchors. The suture or connectingmember can be used in conjunction with one or more cinching or lockingmembers to draw the anchors 814, 816 closer together and secure thetissue plication in place.

With respect to the anchor assembly 704 and anchors 814, 816, the typesof anchors shown and described are intended to be illustrative and arenot limited to the variations shown. Any number of different tissueanchors can be employed with the illustrated device, including, forexample, “T-tag” anchors and reconfigurable “basket” anchors thatgenerally comprise a number of configurable struts or legs extendingbetween at least two collars or support members or reconfigurable meshstructures extending between the two collars. An exemplary “T-tag”anchor and one-way sliding knot is disclosed in U.S. Patent PublicationNo. 2009/0024144 to Zeiner et al., and other exemplary anchors(including “basket” anchors) are disclosed in U.S. Patent PublicationNo. 2005/0251157 to Saadat et al. and U.S. Pat. No. 7,347,863 to Rotheet al., the contents of which are hereby incorporated by reference intheir entirety. Other variations of these or other types of anchors arealso contemplated for use in an anchor assembly 704. Moreover, a singletype of anchor may be used exclusively in an anchor assembly or acombination of different anchor types may be used in an anchor assembly.Furthermore, the cinching or locking mechanisms disclosed are notintended to be limited to any of the particular variations shown anddescribed but may be utilized in any combination with any of the varioustypes of anchors.

FIGS. 9-11 illustrate one embodiment of a method of creating andsecuring one or more gastric plications. The methods of the presentinvention are generally, though not exclusively, characterized byapproaching a tissue wall along a perpendicular axis thereof, andarticulating, pivoting, or positioning jaws of a tissue manipulationdevice so as to be parallel to the tissue surface rather thanperpendicular to it. A tissue grasper can then be used to draw tissuethrough the jaws transversely (i.e., transversely to a longitudinal axisof the jaws) to create a gastric plication.

As described above, the various embodiments of the devices and systemsdisclosed herein can be utilized in a variety of procedures to treat anumber of medical conditions. For example, devices as disclosed hereincan be configured for use during an open surgical procedure.Alternatively, the devices and systems described herein can beconfigured to be passed through one or more layers of tissue during alaparoscopic or other minimally invasive procedure. Furthermore, thedevices can be configured for introduction into a patient via an accessport or other opening formed through one or more layers of tissue, orvia a natural orifice (i.e., endoscopically).

Regardless of how the devices are introduced into a patient's body, themethod of creating a tissue plication can begin by advancing a tissuemanipulation device, such as the device 402 described above, from thedistal end of a transport body, such as an endoscope. The tissuemanipulation device can be advanced toward a tissue wall along aperpendicular axis thereof, similar to the approach of prior art devicesillustrated in FIG. 2. However, prior to engaging tissue with the firstand second jaw members of the device, the device can be moved into anarticulated configuration such that the first and second jaw members aresubstantially parallel to the tissue wall.

FIG. 9 shows one embodiment of this procedure, in which the tissuemanipulation device 402 coupled to the elongate shaft 404 extends from aworking channel of a transport endoscope 902. The elongate shaft 404 canbe oriented along an axis perpendicular to a tissue wall 904, and thearticulation portion 516 of the tissue manipulation device 402 can beactuated to rotate first and second jaw members 504, 506 (only thesecond jaw member 506 is visible in the top view of FIG. 9) into anorientation substantially parallel to the tissue wall 904. Either priorto or following articulation into the position shown in FIG. 9, afastener delivery member 512 that extends from the elongate shaft 904and is coupled to the second jaw member 506 can be urged proximally(i.e., back into the elongate shaft 404) to cause the first and secondjaw members to assume an open configuration, as shown in FIG. 5B.

In order to draw tissue between the first and second jaw members 504,506, a separate tissue grasper 906 may be utilized in conjunction withthe tissue manipulation device 402. The tissue grasper 906 can itselfinclude an elongate shaft 908 having a tool 910 on or near a distal endof the shaft that is configured to engage tissue. The tissue grasper 906can be configured to extend from the endoscope 902 as well, and can beconfigured to move independently of the tissue manipulation device 402.One skilled in the art will appreciate that such tools are generallyutilized in endoluminal procedures and that several different tools maybe utilized for performing a procedure endoluminally. In the illustratedembodiment, the tool 910 at the distal end of the tissue grasper 906 isa corkscrew-shaped member configured to be rotated to engage tissue. Inalternative embodiments, pincers, suction devices, barbs, or otherelements capable of engaging the tissue wall 904 can be employed.

As a result of the fact that the tissue grasper 906 can moveindependently of the tissue manipulation device 402, the tissue graspercan be deployed either before or after positioning of the tissuemanipulation device. For example, in some embodiments the tissuemanipulation device can be articulated into the position shown in FIG.9, and the first and second jaw members can be urged into an openconfiguration by movement of the fastener delivery member 512 prior todeploying the tissue grasper 906. In such an embodiment, the tissuegrasper 906 can be advanced distally through the jaw opening 518 to theposition shown in FIG. 9. Alternatively, the tissue grasper 906 can bedeployed first and the open jaw members can then be articulated over thetissue grasper into the illustrated configuration.

After the tissue grasper 906 has engaged the tissue wall 904, e.g., byrotating the corkscrew tool 910 while in contact with the tissue wall,the tissue grasper 906 can be retracted proximally back into theendoscope 902. As a result of the articulated configuration of the firstand second jaw members, this proximal movement of the tissue grasper 906is transverse to the plane defined by a longitudinal axis of the firstand second jaw members 504, 506. Furthermore, the tissue grasper 906 canbe disposed between the first and second jaw members within the jawopening 518. Accordingly, the tissue grasper 906 can draw a portion ofthe tissue wall 904 through the jaw opening 518 as it moves proximally,thereby creating a fold, or plication, of tissue, as shown in FIG. 10.Drawing tissue through the open jaw members transversely, rather thaninto the open jaws from an open end thereof, allows the creation of atissue plication that is deeper than the length of the first and secondjaw members. Moreover, drawing tissue transversely through the jawmembers can prevent undesired surrounding tissue from beingunintentionally drawn between the jaws. This can be important because itcan be undesirable for some surrounding tissue, such as small bowel,omentum, adjacent organs such as the liver or pancreas, and bloodvessels, to be included in a gastric plication, as complications canarise such as gastric obstruction, tissue necrosis, and undetectedbleeding. By drawing tissue through the open jaw members transversely,larger surrounding tissue or organs can be prevented from entering thejaw opening 518 by the sidewalls of the jaw members themselves.

Following approximation of a portion of the tissue wall 904 into atissue plication disposed between the first and second jaw members 504,506, the fastener delivery member 512 can be urged distally to cause thefirst and second jaw members to clamp down on the tissue disposedtherebetween. In other words, the jaw members and fastener deliverymember can be urged into the configuration shown in FIG. 5C (albeit inthe articulated configuration shown in FIG. 10). The needle assembly 702can then be advanced distally through the fastener delivery member 512such that the needle exits the fastener delivery member, pierces throughthe layers of tissue disposed between the first and second jaw members504, 506, and passes through the opening 608 formed in the first jawmember.

The actuation member 810 on the housing 708 can then be utilized toadvance the anchor assembly 704 distally and ultimately eject the firstdistal anchor 814 from the needle opening 806. The needle assembly 702can then be retracted within the fastener delivery member 512 and thesecond proximal anchor 816 can be ejected from the needle opening 806 onan opposite side of the tissue plication from the first anchor 814.Alternatively, the needle assembly 702 can be retracted and the firstand second jaw members 504, 506 can be opened such that the tissuemanipulation device 402 can be disengaged from the tissue wall 904. Thesecond proximal anchor 816 can then be ejected or, in some embodiments,the procedure can be repeated at a second position and the proximalanchor can be ejected at the second position on the same side of thetissue plication as the distal anchor 814. Regardless, a suture or otherflexible element remains connecting the first and second anchors 814,816. One or more cinching elements can be advanced along the suture todraw the first and second anchors 814, 816 closer together, therebysecuring the tissue plication.

The method described above can be repeated as necessary to implant aplurality of anchors and create a series of tissue plications. FIG. 11illustrates one embodiment in which a first anchor assembly 1102 hasbeen implanted to form a tissue plication P from a portion of a tissuewall 1104. Given the top-view orientation of the figure, only a proximalanchor 1106 of the anchor assembly 1102 is visible, as the distal anchoris below the tissue plication P.

Also shown in FIG. 11 is the tissue manipulation device 402 applying asecond anchor assembly at a second location a distance D apart from theposition of the first anchor assembly 1102. As shown in the figure, byapplying a series of anchors in a line along the tissue wall 1104, thetissue plication P can be extended to any length. While the distance Dcan be chosen according to the type of tissue and degree of fasteningrequired, in some embodiments, the distance D between adjacent anchorassemblies can be 2 cm or less. If basket anchors are used, the distanceD between adjacent anchor assemblies can be 3 cm or less. In otherembodiments, the distance between anchors can be selected based on avariety of factors including, for example, the size and type of theanchors used, as well as the thickness of the tissue. FIG. 11 alsoillustrates the natural deflection that can occur along the length ofthe elongate shaft 404 due to forces being exerted during actuation ofthe various components of the tissue manipulation device 402 (e.g.,actuation of the fastener delivery member 512, articulating portion 516,delivery of an anchor assembly, etc.).

The method of extending a tissue plication shown in FIG. 11 can berepeated to create a single line of anchors along a plication, ormultiple lines of anchors securing a plication. Multiple lines ofanchors can be formed along a plication by drawing the tissue throughthe first and second jaw members 504, 506 to different depths. Thismethod can be used, for example, to create a very deep tissue plication.In one embodiment, a first line of anchors can be deployed to create atissue plication of a first depth, and then a second line of anchors canbe deployed by drawing the plication through the first and second jawmembers beyond the position of the first line of anchors to extend thedepth of the tissue plication.

FIG. 12 illustrates a cross-sectional view of the tissue plication P,showing a single anchor assembly 1202 securing the plication. A firstdistal anchor 1204 is visible on one side of the tissue plication P, anda second proximal anchor 1206 is visible on an opposite side of theplication. As noted above, in some embodiments both anchors can bepositioned on a same side of the tissue plication with a suture or otherconnecting element extending through the tissue and between the anchors.The two anchors 1204, 1206 can be connected by a suture or flexibleelement 1208 that, in some embodiments, can have a terminal end that isa loop 1210. The suture 1208 can be formed from a variety of materialssuch as monofilament, multifilament, or any other conventional suturematerial, elastic or elastomeric materials, e.g., rubber, etc. Disposedalong the length of the suture 1208 can be one or more locking orcinching mechanisms 1212 that provide for movement of an anchor alongthe suture in a first direction and preferably lock, inhibit, or preventthe reverse movement of the anchor back along the suture.

One skilled in the art will appreciate that the methods described abovecan be adapted for use with approach angles that are either exactlyperpendicular to a tissue wall, substantially perpendicular, or at anyother angle to the tissue wall. The general principle remains that thetissue engaging jaw members of the device can be articulated to anyrequired degree such that they assume a position substantially parallelto the tissue wall.

FIGS. 13A-13C illustrate exemplary embodiments of an articulatingportion that can be employed in a tissue manipulation device to providevarious ranges of motion. For example, an articulating portion can beformed as a hinge 1302 that allows two-dimensional rotational movement,as shown in FIG. 13A. Alternatively, freedom of movement can beaccomplished by using a ball-and-socket joint 1304 as an articulatingportion, as shown in FIG. 13B. In another embodiment shown in FIG. 13C,an articulating portion can be created by connecting a plurality ofjointed segments 1306. Each segment 1306 can move in a certain range ofmotion with respect to each adjacent segment. The cumulative effect ofeach of the segments 1304 can provide a large range of motion for thearticulating portion. In some embodiments, a similar strategy can beused to connect multiple ball-and-socket joints to produce a greatercumulative range of motion. Still further, use of ball-and-socket jointsor jointed segments can allow the articulating portion to move in threedimensions, not simply pivot within a particular plane, as with thehinge of FIG. 13A.

The articulating portion can be actuated in a variety of manners. FIG.14 illustrates one exemplary embodiment in which an articulationactuating member 1402 in the form of a wire is coupled to the first jawmember 504 at a location distal to the articulating portion 516. In someembodiments, the articulation actuating member 1402 can be coupled tothe first jaw member 504 on a sidewall thereof, such that tensioning thearticulation actuating member can actuate the articulation portion 516and cause the first and second jaw members to move from the straightconfiguration shown in FIG. 14 to the articulated configuration shown inFIG. 6C. There are a variety of articulation actuating membersavailable, all of which are within the scope of the invention. Forexample, in some embodiments the articulation actuating member caninclude one or more connecting members, which can include cables,ribbons, bands, etc. In other exemplary embodiments the articulationactuating member can include any mechanically, electrically,pneumatically, or hydraulically powered actuators that can beincorporated into the tissue manipulation device 402. In someembodiments, other actuators, such as springs, shape memory alloys, andother mechanical linkages can also be used. In other embodiments, thearticulation actuation member can be incorporated into the fastenerdelivery member 512 such that movement of the fastener delivery membercan both open and close the first and second jaw members, and effectarticulation of the device between a straight and articulatedconfiguration. Furthermore, one or more actuating members can also beincluded on other surfaces (e.g., an opposing sidewall from that shownin FIG. 14) to either recover from an articulated configuration (e.g.,for removal from a patient's body) or to allow for articulation in morethan one direction.

The one or more articulation actuating members 1402 can be coupled tothe tissue manipulation device 402 in any manner known in the art.Moreover, in some embodiments, the articulation actuating members 1402can be coated or covered to protect from catching or otherwise damagingsurrounding tissue during use. FIG. 15 illustrates one embodiment of asheath 1502 that can be disposed around any of the elongate shaft 404,first jaw member 504, and fastener delivery member 512. The sheath 1502can include an inner lumen 1504 to house one or more components of thetissue manipulation device 402, and also includes one or more sub-lumens1506 formed in a sidewall thereof to house the wire articulationactuating member 1402.

Furthermore, and although not shown in the attached figures, any of theexterior components of the tissue manipulation device 402 or surgicalinstrument 400 can be covered, coated, or can contain additionalfeatures or geometry to minimize the risk of unintentional tissue damageduring insertion, operation, or removal. Exemplary features includeblunt surfaces, tapered tips, fillets, chamfers, elastomericcoatings/coverings, or any other similar feature known to one skilled inthe art.

The methods disclosed above demonstrate the use of a device of thepresent invention to create and secure a gastric plication. The devicesand systems of the present invention can be utilized with a variety ofmethods of plication placement within the gastric cavity. For example,some data has shown that reduction of gastric volume throughinvagination of the greater curvature of the stomach has yieldedsignificantly larger excess weight loss percentage than invagination ofthe lesser curvature. Exemplary methods of plication formation andplacement on the anterior and posterior surfaces of the gastric cavityare disclosed in U.S. application Ser. No. 13/326,625 to Felder et al.,the contents of which are hereby incorporated by reference in theirentirety.

By way of example, in an exemplary method, one or more gastricplications can be formed on an anterior or posterior wall of the greatercurvature of the stomach. One embodiment of an exemplary method forforming plications is illustrated in FIGS. 16A and 16B. As shown in FIG.16A, a device as disclosed herein can be inserted through a patient'sesophagus and into the stomach cavity. The device can then be positionedand/or articulated to access the anterior or posterior wall of thestomach near or within the fundus. Finally, a plication can be createdand secured using, for example, the method described above. This leavesa secured gastric plication, as shown by “Fold A” of FIG. 16A.

To create additional plications, the surgical device can be moved fromthe position of “Fold A” shown in FIG. 16A to a second position labeled“Fold B” in FIG. 16B. The above process can then be repeated to createand secure a second plication. If necessary, the surgical device canagain be moved from the position of “Fold B” to a third position labeled“Fold C.” Additional folds can be made as necessary, forming afan-shaped pattern. After forming and securing all plications, thesurgical device can be retracted back out of the gastric cavity throughthe esophagus, leaving only the secured plications.

The multiple plications discussed above can be formed in a clockwise orcounterclockwise direction (i.e., moving from Fold A to Fold C, or FoldC to Fold A). In addition, plications can be formed on both the anteriorand posterior walls of the greater curvature of the stomach. In formingplications on both walls, the methods of the present invention caninclude forming all plications on one wall before the other, oralternating between the two. In addition, plications can be formed onboth walls in a particular section of the stomach before alternately orotherwise forming plications in other sections of the stomach. Further,plications can be formed in any of a proximal or a distal direction. Forexample, plications can be formed on both the posterior and anteriorwalls in or near the fundus before forming plications on alternate wallsin a distal to proximal direction in other areas of the stomach. Stillfurther, the respective folds created on the anterior and posteriorwalls of the stomach need not be attached to each other. These methodscan provide the benefit of limiting the impact of a decreasing workingspace as the multiple plications are formed and secured.

In another embodiment, multiple plications can be formed in anend-to-end fashion to create a single extended plication, rather thanthe fan-shaped pattern described above. To do so, a surgical deviceaccording to the teachings of the invention can be inserted into apatient's stomach through the esophagus. Once in the stomach, thesurgical device can be positioned along the anterior wall of the stomachnear or within the antrum, as shown in FIG. 17A. The surgical device canbe utilized according to any of the methods described above to form andsecure a first gastric plication labeled “Fold A” in FIG. 17A.

Following formation of the first plication, the surgical device can beretracted toward the esophagus. Once the surgical device is in aposition to create a gastric plication that extends from the firstgastric plication (labeled “Fold A”), the surgical device can beactuated to create a second gastric plication labeled “Fold B” in FIG.17B.

The above process can be repeated again to create a third gastricplication (labeled “Fold C”), as shown in FIG. 17C. Depending on thesize (e.g., length) of the jaw members of the surgical device, theprocess may be repeated more or fewer times in order to create a desirednumber of gastric plications.

Similarly to the methods of forming plications in a fan-shaped patterndescribed above, the above methods contemplate forming all plications onan anterior wall of the stomach followed by forming all plications on aposterior wall, or alternately forming plications on the anterior walland the posterior wall. Further, plications may be formed in both wallsof one section of a cavity before forming plications alternately or inanother manner in another section of the cavity. In addition, theplications formed on the anterior wall need not be attached to those onthe posterior wall of the stomach. Still further, the plications can beformed in a distal to proximal order, as shown in the figures, or in aproximal to distal order (i.e., moving from Fold C to Fold A). Followingthe formation of the final plication, the surgical device can be removedfrom the stomach via the esophagus. One skilled in the art willappreciate that a combination of the embodiments described above may beused (e.g., first forming a plication in or near the fundus, and thenforming a plication in a distal to proximal order, or first forming atleast one plication in the form of a fan and then forming at least oneplication in the form of a line), as shown in FIG. 18. There are anumber of variations in the order and direction in which plications canbe formed in the cavity, all of which are considered within the scope ofthe present invention.

The devices disclosed herein can be designed to be disposed after asingle use, or they can be designed for multiple uses. In either case,however, the device can be reconditioned for reuse after at least oneuse. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility or bya surgical team immediately prior to a surgical procedure. Those skilledin the art will appreciate that reconditioning of a device can utilize avariety of techniques for disassembly, cleaning/replacement, andreassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present invention.

For example, the devices disclosed herein may be disassembled partiallyor completely. In particular, and by way of example only, the first andsecond jaw members of the tissue manipulation device may be decoupledfrom the elongate shaft and fastener delivery member. Furthermore, anyfastener deployment assembly may be removed from the fastener deliverymember and replaced or cleaned and reloaded. The first and second jawmembers themselves may also be decoupled and cleaned or replaced priorto reassembly. The articulating portion may also be disassembled andcleaned or replaced. One skilled in the art will appreciate that everycomponent of the devices described herein can be disassembled andcleaned or replaced prior to reassembling the device.

Preferably, the devices described herein will be processed beforesurgery. First, a new or used instrument can be obtained and, ifnecessary, cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK® bag. The container and itscontents can then be placed in a field of radiation that can penetratethe container, such as gamma radiation, x-rays, or high-energyelectrons. The radiation can kill bacteria on the instrument and in thecontainer. The sterilized instrument can then be stored in the sterilecontainer. The sealed container can keep the instrument sterile until itis opened in the medical facility. In many embodiments, it is preferredthat the device is sterilized. This can be done by any number of waysknown to those skilled in the art including beta or gamma radiation,ethylene oxide, steam, and a liquid bath (e.g., cold soak).

All papers and publications cited herein are hereby incorporated byreference in their entirety. One skilled in the art will appreciatefurther features and advantages of the invention based on theabove-described embodiments. Accordingly, the invention is not to belimited by what has been particularly shown and described, except asindicated by the appended claims.

What is claimed is: 1.-17. (canceled)
 18. A method of acquiring andfixating tissue, comprising: inserting into a body lumen a tissuegrasper, an elongate shaft, and an end effector having first and secondjaws that are pivotally coupled to a distal end of the elongate shaft;pivoting the end effector with respect to the elongate shaft in a firstplane; pivoting the first and second jaws in a second plane that istransverse to the first plane; positioning the tissue grasper to engagetissue; drawing tissue through the first and second jaws by moving thetissue grasper transversely with respect to the first and second jaws;and delivering a fastener through the tissue disposed between the firstand second jaws from a fastener delivery member coupled to the secondjaw.
 19. The method of claim 18, wherein inserting the end effector andelongate shaft into a body lumen comprises positioning the elongateshaft perpendicular to an inner surface of the body lumen, and pivotingthe end effector in the first plane comprises positioning the endeffector such that a longitudinal axis of the end effector is parallelto the inner surface of the body lumen.
 20. The method of claim 18,wherein moving the tissue grasper transversely with respect to the firstand second jaws comprises moving the tissue grasper perpendicular to alongitudinal axis of the first and second jaws.
 21. The method of claim18, wherein pivoting the end effector with respect to the elongate shaftincludes translating an articulation actuating member parallel to alongitudinal axis of the elongate shaft.
 22. The method of claim 18,wherein delivering the fastener includes moving a fastener deliverymember from a low-profile delivery configuration in which the fastenerdelivery member is positioned substantially within a channel formed inthe second jaw to an open configuration in which a distal portion of thefastener delivery member is positioned substantially outside of thechannel.
 23. The method of claim 22, wherein delivering the fastenerfurther includes extending a needle from the fastener delivery membersuch that the needle passes through openings formed in the first andsecond jaws, as well as through the tissue disposed therebetween.
 24. Amethod of acquiring and fixating tissue, comprising: positioning an endeffector coupled to a distal end of an elongate shaft at a surgical sitesuch that a longitudinal axis of the elongate shaft lies in a firstplane that is defined by lengths of first and second jaws of the endeffector that are pivotally coupled to one another; articulating the endeffector relative to the elongate shaft such that the first plane istransverse to the longitudinal axis of the elongate shaft; and drawingtissue through the first and second jaws in a direction transverse tothe first plane.
 25. The method of claim 24, wherein drawing tissuethrough the first and second jaws includes engaging tissue with a tissuegrasper capable of moving independently from the end effector.
 26. Themethod of claim 24, wherein the end effector is positioned such that thefirst plane is transverse to a tissue surface prior to articulation ofthe end effector and is parallel to the tissue surface afterarticulation of the end effector.
 27. The method of claim 24, furthercomprising delivering a fastener through tissue disposed between thefirst and second jaws.
 28. The method of claim 27, wherein the fasteneris delivered through a flexible fastener delivery member that extendsfrom the elongate shaft and is coupled to the second jaw member.
 29. Themethod of claim 28, wherein delivering the fastener includes extending aneedle from the flexible fastener delivery member such that the needlepasses through openings formed in the first and second jaws, as well asthrough the tissue disposed therebetween.
 30. A method for acquiring andfixating tissue, comprising: inserting into a body lumen an end effectorthat is coupled to an elongate shaft, the end effector being arrangedsuch that a longitudinal axis of the elongate shaft lies in a firstplane that is defined by relative movement of first and second jaws ofthe end effector that are pivotally coupled to one another; approachinga tissue surface such that the first plane and the longitudinal axis ofthe elongate shaft are transverse to the tissue surface; articulatingthe end effector relative to the elongate shaft such that the firstplane is substantially parallel to the tissue surface and transverse tothe longitudinal axis of the elongate shaft; drawing tissue through thefirst and second jaws using a tissue grasper that can move independentlyfrom the end effector; and delivering a fastener through tissue disposedbetween the first and second jaws.
 31. The method of claim 30, whereinthe end effector is articulated relative to the elongate shaft about apivot point located proximal to a location of pivotal coupling betweenthe first and second jaws of the end effector.
 32. The method of claim30, wherein delivering the fastener includes moving a fastener deliverymember from a low-profile delivery configuration in which the fastenerdelivery member is positioned substantially within a channel formed inthe second jaw to an open configuration in which a distal portion of thefastener delivery member is positioned substantially outside of thechannel.
 33. The method of claim 32, wherein delivering the fastenerfurther includes extending a needle from the fastener delivery membersuch that the needle passes through openings formed in the first andsecond jaws, as well as through the tissue disposed therebetween.